Cyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer

Treatment for metastatic breast cancer commonly involves the use of the chemotherapy drug
nab-paclitaxel. Nab-paclitaxel is a special preparation of paclitaxel inside a protein
layer of albumin. Other studies have shown Cyclosporine A (CsA) may block the progression
of advanced breast cancer. The combination of nab-paclitaxel and CsA is considered
investigational which means it has not been approved by the US Food and Drug Administration,
FDA. Participants on this study will receive nab-paclitaxel through a vein in the arm weekly
3 weeks out of 4, in the outpatient clinic. On the same day as the first infusion of
nab-paclitaxel, participants will begin taking CsA tablets twice a day by mouth.
Participants will continue to receive study treatment as long as their tumor responds. If
the tumor does not respond or the participant experience severe side effects from study
treatment, she will be removed from the study and offered other therapies, if that is
appropriate.

Inclusion Criteria

- Female or male patients with adenocarcinoma of the breast with metastatic disease.

- Patients may have evaluable or measurable disease.

- Age > 18 years.

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control or abstinence) prior to study entry and
for the duration of study participation. Should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately.

- Able to swallow and retain oral medication.

Exclusion Criteria

- Patients who have had any major surgery, hormonal therapy (other than replacement),
chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
prior to entering the study or patients who have not recovered from adverse events
due to agents administered more than 4 weeks earlier. Prior nab-paclitaxel is
allowed.

- Patients may not be receiving any other investigational agents or receiving
concurrent anticancer therapy.

- Patients with uncontrolled brain metastases or leptomeningeal disease or active
neurologic impairment.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Cyclosporine A or nab-paclitaxel.

- Pregnant or lactating (Cyclosporine A is excreted into breast milk) females

- Patients with GI tract disease resulting in an inability to take oral medication,
malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures
affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative
colitis).

- HIV-positive patients are excluded since Cyclosporine A may result in further
immunosuppression